Teleflex recalls specific lot numbers of Pilling O'Reilly esophageal retractors due to incomplete pre-cleaning instructions in the manual. Affected users should check their product details and contact Teleflex for guidance.
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Teleflex is recalling certain models of Pilling O'Reilly esophageal retractors because the cleaning instructions in the manual are incomplete. This could lead to improper cleaning and potential infection risks if the device isn't used correctly.
The incomplete pre-cleaning instructions in the manual could lead to improper cleaning of the device. This might increase the risk of infection or contamination if the device is not cleaned correctly before use.
Healthcare professionals who use the Pilling O'Reilly esophageal retractors for ENT procedures are most likely affected. Patients using these devices during surgery may also be at risk if the cleaning instructions are not followed properly.
Check the product label for lot numbers B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, S2, U0, V2, W1. The device is a medical ENT retractor used in surgical procedures.
Identify the lot number on the device to confirm if it is affected by this recall.
The recall is due to incomplete pre-cleaning instructions in the Instructions for Use (IFU), which could lead to improper cleaning and potential infection risks.
Check the lot number on the device to see if it is affected. If it is, contact Teleflex for further instructions.
The recall does not specify a fix; the remedy is null, so users should follow the cleaning instructions in the manual as provided.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-2095-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-2095-2023 from Teleflex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.